Soleil Toujours
- Product NDC
- 58443-0555
- 11-digit product format
- 584430555
- Labeler code
- 58443
- Product ID
- 58443-0555_e6627a59-c59a-c1c9-e053-2a95a90ae506
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Homosalate, Octisalate
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Prime Enterprises Inc.
- Application
- M020
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2017-02-20
- Marketing end
- 0000-00-00
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE
- Active strength
- 25 mg/mL; mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 58443-0555 | I | Inactivated by FDA | 2026-11-12 | ||
| excluded package | package | 58443-0555 | 58443-0555-3 | I | Inactivated by FDA | 2026-11-12 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58443-0555-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58443-0555-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 58443-0555-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 58443-0555-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 58443-0555-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 58443-0555-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 58443-0555-3 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 58443-0555-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 58443-0555-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 58443-0555-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 58443-0555-3 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 58443-0555-3 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 58443-0555-3 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 58443-0555-3 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 58443-0555-3 | 1332a3947898… | d4bfe170f9cd… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58443-0555-3 | 2024-01-30 | C162847 | 48780-1 | 1030e365-6dbb-111a-e063-dadaa90a10e2 | Soleil Toujors Set + Protect Micro Mist Broad Spectrum SPF 30 Sunscreen |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58443-0555-3 | Soleil ToujoursBroad Spectrum SPF 30 Sunscreen | 59 mL in 1 TUBE | LOTION | 59 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58443-0555 | SOLEIL TOUJOURS BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE) LOTION [PRIME ENTERPRISES INC.] | 1 | Legacy NDC, 1 package rows | 20220818_e6629504-b211-4cd1-e053-2a95a90a2826.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Refreshing Water Hydration Stick SPF 50 | AVOBENZONE OCTISALATE HOMOSALATE OCTOCRYLENE | COOLA LLC | 6da037f8-bedb-467a-b534-e44752120f2c | 2024-12-27 | Warnings | M020 |
| Nu Skin ageLOC Radiant Day Broad Spectrum SPF 22 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | NSE Products, Inc. | 649a9c28-bfd4-404c-90d5-5d0ea8c7b645 | 2024-12-27 | Warnings | M020 |
| Kiehls Since 1851 Activated Sun Protector For Face and Body Broad Spectrum SPF 50 Sunscreen | TITANIUM DIOXIDE | L'Oreal USA Products Inc | 87496037-36ca-4c5f-973f-46626cf4096e | 2024-12-27 | Warnings | M020 |
| PORESCREEN SPF40 | ZINC OXIDE | Dermalogica, LLC. | 37a7362a-b251-4d3a-a957-65d8f338fa12 | 2024-12-27 | Warnings | M020 |
| COOLA Classic Face Sunscreen Fragrance-Free SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | COOLA LLC | 12ff4689-f7e2-49db-8848-608c61b41ef0 | 2024-12-27 | Warnings | M020 |
| NUDESCREEN LIP PRIMER SPF 30 - NATURAL TINT | ZINC OXIDE | Bentley Laboratories, LLC | 6edd51e5-1c42-4e66-b5ca-abfea2dad8f8 | 2024-12-27 | Warnings | M020 |
| Tone Control Morning Cream SPF 15 | OCTOCRYLENE AND OCTISALATE CREAM | Bentley Laboratories, LLC | b4e3cd1c-ae42-4995-a314-96d24d328e41 | 2024-12-27 | Warnings | M020 |
| ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light) | ZINC OXIDE | ZO Skin Health, Inc. | be25489e-c3bf-77c5-e053-2a95a90a30de | 2024-12-27 | Warnings | M020 |
| COOLA Classic Body Sunscreen Tropical Coconut SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | COOLA LLC | 55ad5d2f-a855-491e-a287-13689f8abff1 | 2024-12-27 | Warnings | M020 |
| RODAN and FIELDS UNBLEMISH | TITANIUM DIOXIDE, ZINC OXIDE | Bentley Laboratories, LLC | 2b3b6b62-364f-4aba-8024-3a73752b4c56 | 2024-12-27 | Warnings | M020 |
| Powerbright Moisturizer SPF 50 | OCTOCRYLENE, HOMOSALATE, AVOBENZONE, AND OCTISALATE | Dermalogica, LLC. | 02c731ee-c5cb-4158-9b1f-e826593c3526 | 2024-12-27 | Warnings | M020 |
| INVISIBLE PHYSICAL DEFENSE SPF30 | ZINC OXIDE | Dermalogica, Inc. | 2e5e6861-25ea-4605-8e59-41d852c002b7 | 2024-12-27 | Warnings | M020 |
| COOLA CLASSIC FACE SUNSCREEN Cucumber Broad Spectrum SPF 30 | AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE | COOLA LLC | dec3b0d1-f06e-4acf-8ba2-64167e774abc | 2024-12-27 | Warnings | M020 |
| Clearing Defense SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Dermalogica, Inc. | 2388ae53-0a61-43c0-8936-c639887a5649 | 2024-12-26 | Warnings | M020 |
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06c5efde-42e3-e4fc-e063-6394a90a491d | 2024-12-26 | Warnings | M020 |
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06c62206-d832-8d9a-e063-6394a90a4c69 | 2024-12-26 | Warnings | M020 |
| Morphe SPF 30 Broad Spectrum Sunsetter Setting | OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE | COSMAX USA, CORPORATION | 0d34406f-9dd0-3909-e063-6394a90ab9f9 | 2024-12-26 | Warnings | M020 |
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06c64cc0-be42-c210-e063-6394a90a6d9a | 2024-12-26 | Warnings | M020 |
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06c61c42-edda-1ebd-e063-6294a90aee13 | 2024-12-26 | Warnings | M020 |
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06c62206-d839-8d9a-e063-6394a90a4c69 | 2024-12-26 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58443-0555-3 | 58443055503 | 59 mL in 1 TUBE (58443-0555-3) | 59 ml | 2017-02-20 | 0000-00-00 | No | No | Current |